21-Jan-2022 | Market Research Store

Evaxion Biotech, a clinical research biotech company leader in the innovation of AI-driven immunotherapies to enhance the lives of cancer patients and people suffering from infectious diseases, recently announced that it has received approval from the Therapeutic Goods Department of Australia to begin a clinical phase 2b trial of cancer immunotherapy EVX-01 in conjunction with Merck & Co., Inc.'s anti-PD-1 therapy KEYTRUDA® (pembrolizumab).

Evaxion Biotech is a clinical-Research AI-immunology TM platform firm dedicated to understanding the human immune system in an effort to find and develop innovative immunotherapies for cancer, viral infections, and bacterial illnesses. Evaxion is building a wide pipeline of unique product candidates relying on its patented and modular AI-immunology technology.

Regulatory Approval Granted To Evaxion Biotech To Begin Phase II Trial For Treating Melanoma.

The open-label, single-arm study will assess the effectiveness and safety of EVX-01 in combination with KEYTRUDA® in approximately 100 checkpoint inhibitor treatment-naive people with unresectable or metastatic melanoma. The main objective will be the overall response. The research is planned to begin in Q2.

Evaxion CEO, Lars Wegner stated: “Australian clearance for our Phase 2b trial of our lead product EVX-01 is a significant step forward for Evaxion and our exciting pipeline of immunotherapies. Data from the Phase 1/2a trial have shown that EVX-01 may be able to dramatically improve the treatment landscape in melanoma and possibly other cancers and we are excited to continue the clinical progress of our lead drug candidate EVX-01 in collaboration with Merck. This new Phase 2b trial, combining EVX-01 and KEYTRUDA®, addresses a significant medical need and a potential multibillion dollar market. There could be potential further benefits from combining EVX-01 with checkpoints inhibitors such as KEYTRUDA®, and so this study may enable expansion into many other types of cancers, addressing a market of well over $100 billion.”

EVX-01, a unique patient-specific cancer neoepitope immunotherapy based on Evaxion's patented PIONEERTM AI technology, is being studied in a Phase 1/2a study for the treatment of patients with melanoma. According to the results of this experiment, EVX-01 in conjunction with anti-PD-1 for the treatment of metastatic melanoma helped 67 percent of the nine patients, compared to just 40 percent of patients who had the checkpoint inhibitor alone. With EVX-01 in conjunction with anti-PD-1, 22% of patients in the trial obtained a full response.

Dohme Corp and Merck Sharp a subsidiary of Merck & Co., Kenilworth, NJ, USA, owns the trademark KEYTRUDA®.

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